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by mirimir
2540 days ago
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Approved drugs are listed here: https://www.accessdata.fda.gov/scripts/cder/daf/ Also: https://www.accessdata.fda.gov/scripts/cder/ob/index.cfm And: https://www.drugs.com/history/ Physicians can only prescribe FDA-approved drugs. Only brand drugs are approved on their own. Generic drugs are approved, with much less documentation required. There's no need to demonstrate effectiveness, safety, etc. Applicants must only demonstrate that products are therapeutically equivalent to approved brand drugs. That's mainly about chemical identity, purity, and rate and degree of absorption. At Drugs@FDA, search for a brand name. If there are generics, you'll see "Therapeutic Equivalents for NDA ...". Clicking that will display links to them. If there's no listed brand drug, there's nothing for a generic to be equivalent to. |
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